| CTRI Number |
CTRI/2024/10/074797 [Registered on: 07/10/2024] Trial Registered Prospectively |
| Last Modified On: |
20/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
“A study comparing post surgery outcomes in two types of breast implants used in reconstruction after a mastectomy: one placed above the chest muscle (prepectoral) and one placed below the chest muscle (subpectoral)†|
|
Scientific Title of Study
|
An open-label, parallel-group randomized controlled trial comparing post-mastectomy prepectoral and subpectoral implant based breast reconstruction in breast cancer patients |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gajendra Pandit |
| Designation |
SENIOR RESIDENT |
| Affiliation |
AIIMS |
| Address |
1st Floor,Department of surgical onclogy, BRAIRCH-AIIMS, Ansari Nagar
South
DELHI
110049
India |
| Phone |
9471166594 |
| Fax |
|
| Email |
gpandit113@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ASHUTOSH MISHRA |
| Designation |
Associate Professor |
| Affiliation |
BRAIRCH AIIMS, New Delhi |
| Address |
Room no.244, 2nd Floor, Department of surgical onclogy, BRAIRCH-AIIMS, Ansari Nagar
South
DELHI
110049
India |
| Phone |
9650638722 |
| Fax |
|
| Email |
drashutoshmishra11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR GAJENDRA PANDIT |
| Designation |
SENIOR RESIDENT |
| Affiliation |
BRAIRCH AIIMS, New Delhi |
| Address |
1st floor, Department of surgical onclogy, BRAIRCH-AIIMS, Ansari Nagar
South
DELHI
110049
India |
| Phone |
9650638722 |
| Fax |
|
| Email |
gpandit113@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of surgical onclogy, BRAIRCH-AIIMS, Ansari Nagar, New Delhi, 110049, India
|
|
|
Primary Sponsor
|
| Name |
AIIMS NEW DELHI |
| Address |
BRAIRCH-AIIMS NEW DELHI |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR GAJENDRA PANDIT |
BRAIRCH-AIIMS |
Room no. 244, Department of surgical oncology, Ansari Nagar
South
DELHI |
9471166594
gpandit113@gmail.com |
| DR GAJENDRA PANDIT |
NCI-AIIMS |
D wing, 2nd Floor, Department of surgical oncology OPD Block, Badsa
Jhajjar
HARYANA |
9471166594
gpandit113@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee for post graduate research, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Prepectoral implant based breast reconstruction |
Implant-based breast reconstruction post mastectomy in which placing the implant above the chest muscle (prepectoral) and follow up the patient on days 10, 30, 60, and 90 days post-surgery to see post operative outcomes including wound dehiscence, hematoma, seroma, infection, mastectomy skin necrosis, loss of implant, implant exposure/extrusion, animation deformity, and capsular contraction, and quality of life. |
| Intervention |
Subpectoral implant based breast reconstruction |
Implant-based breast reconstruction post mastectomy in which placing the implant below the chest muscle that is below pectoralis major muscle (subpectoral) and follow up the patient on days 10, 30, 60, and 90 days post-surgery to see post operative outcomes including wound dehiscence, hematoma, seroma, infection, mastectomy skin necrosis, loss of implant, implant exposure/extrusion, animation deformity, and capsular contraction, and quality of life. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
ECOG 0 and 1
Patient undergoing mastectomy for breast cancer and risk reducing surgery
Presumptive adequate skin flap thickness greater than 8mm on mammogram
Patient should be well oriented and coherent
Both unilateral and bilateral breast surgery cases will be included
|
|
| ExclusionCriteria |
| Details |
Patients with intraoperatively inadequate skin flaps
Metastatic/Recurrent Breast cancer
Pregnant or lactating women
Patient refused for consent for the study.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the overall postoperative outcomes of implant-based breast reconstruction between prepectoral and subpectoral surgical techniques |
10th day, 30th day, 60th day, and 90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare between the 2 groups mentioned above:
1. Quality of life assessed by using BREAST-Q Version 2.0
2. Length of hospital stay.
|
2 years |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In India, there is significant variability in breast reconstruction practices. This underscores the need for randomized clinical trials to methodically assess postoperative outcomes and quality of life associated with prepectoral and subpectoral implant-based breast reconstruction techniques. |